Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.
Pharmacy Services Programme, Ministry of Health Malaysia, Petaling Jaya, Malaysia.
BioDrugs. 2022 Jul;36(4):489-508. doi: 10.1007/s40259-022-00541-x. Epub 2022 Jul 1.
While biosimilars are less expensive than their originator biologics, various factors are known to impede their uptake in clinical practice including concerns regarding their interchangeability, efficacy, and safety. Pharmacists are well positioned to promote the adoption of biosimilars, thus, the aim of the review was to assess pharmacists' knowledge and perceptions of biosimilars to identify the need for pharmacist-directed biosimilar education.
We conducted a systematic literature search for published articles indexed in MEDLINE via EBSCOHOST, Web of Science, Scopus, Cochrane Library, Dimensions, and Google Scholar databases. We included studies written in English from their earliest publication dates until December 2021. Only studies concerning pharmacists' perspectives on biosimilars were included. Two reviewers extracted data from the studies that included pharmacists' knowledge, perceptions, and opinions about interchangeability and automatic substitution of biosimilars. We also assessed the methodological quality of the included studies using the Joanna Briggs Institute Analytical Cross-Sectional Studies Assessment (JBI-ACSSA) for quantitative studies and the Critical Appraisal Skills Programme (CASP) for qualitative studies.
Out of the 22 studies included in the review, 19 were cross-sectional quantitative studies, and the other three were qualitative studies. The sample size of the included studies ranged from 19 to 1500 participants. The level of knowledge of biosimilars graded as good, considerable, above average, or excellent among pharmacists varied from study to study, with a range of 47-86%. Only 22-51% of pharmacists were comfortable if biosimilars were prescribed for all of the indications previously used for the originator products. Pharmacists' acceptability of switching from the originator to a biosimilar also varied, with a range of 26-84%. However, most pharmacists viewed the substitution of the originator with a biosimilar without physicians' permission as unacceptable. Data from three studies reported that 22-74% of pharmacists had attended biosimilar training. They obtained information about biosimilars from scientific publications, pharmaceutical companies, and continuing education. Based on the criteria of JBI-ACSSA and CASP, the overall methodological quality of the studies ranged from moderate to high. The majority of the studies did not describe the sampling methods used and the strategies to deal with confounding factors.
Pharmacists' knowledge and perception about biosimilars varied and were limited, especially about interchangeability and substitution, efficacy, safety, and indication extrapolation. A better understanding of biosimilars amongst pharmacists could help them to encourage prescribers' acceptance of biosimilars.
生物类似药的价格低于原创生物制品，但已知有各种因素会阻碍其在临床实践中的应用，包括对其可互换性、疗效和安全性的担忧。药剂师在推广生物类似药的应用方面具有得天独厚的优势，因此，本综述的目的是评估药剂师对生物类似药的知识和看法，以确定需要药剂师指导的生物类似药教育。
我们通过 EBSCOHOST 上的 MEDLINE、Web of Science、Scopus、Cochrane 图书馆、Dimensions 和 Google Scholar 数据库对已发表的文章进行了系统的文献检索。我们纳入了自最早发表日期至 2021 年 12 月的以英语撰写的研究。仅纳入了涉及药剂师对生物类似药观点的研究。两位审查员从研究中提取了关于药剂师对可互换性和生物类似药自动替代的知识、看法和意见的数据。我们还使用 Joanna Briggs 研究所分析性横断面研究评估 (JBI-ACSSA) 对定量研究和批判性评估技能计划 (CASP) 对定性研究进行了纳入研究的方法学质量评估。
在综述中纳入的 22 项研究中，19 项为横断面定量研究，另外 3 项为定性研究。纳入研究的样本量从 19 到 1500 名参与者不等。药剂师对生物类似药的知识水平各不相同，从一项研究到另一项研究的评分从良好、相当、高于平均水平到优秀不等，范围在 47-86%之间。只有 22-51%的药剂师在生物类似药被开用于原创产品的所有适应症时感到舒适。药剂师对从原创产品转换为生物类似药的接受程度也各不相同，范围在 26-84%之间。然而，大多数药剂师认为在没有医生允许的情况下用生物类似药替代原创产品是不可接受的。来自三项研究的数据显示，22-74%的药剂师参加过生物类似药培训。他们从科学出版物、制药公司和继续教育中获取有关生物类似药的信息。根据 JBI-ACSSA 和 CASP 的标准，研究的整体方法学质量从中等到高不等。大多数研究没有描述使用的抽样方法和处理混杂因素的策略。
药剂师对生物类似药的知识和看法各不相同且有限，特别是对可互换性和替代、疗效、安全性和适应症外推方面。药剂师对生物类似物的更好理解可以帮助他们鼓励处方医生接受生物类似物。
